Zai Lab and Argenx have announced receipt of approval from the National Medical Products Administration (NMPA) of China for the supplemental biologics license application (sBLA) for VYVGART Hytrulo 1,000mg vial for treating chronic inflammatory demyelinating polyneuropathy (CIDP) in adults.
This once-weekly 30-90-second subcutaneous (SC) injection reportedly marks the first and only approval in China for a therapy to treat this immune-mediated neuromuscular disorder of the peripheral nervous system.
The approval is based on the positive outcome of the randomised, double-blind, placebo-controlled multicentre ADHERE study. The trial comprised an open-label period to detect responders, followed by a randomised-withdrawal, double-blinded period to further evaluate the therapy.
Patients from the Greater China region were enrolled in the ADHERE trial by Zai Lab, and the treatment response observed was in line with global study results.
A 69% reduction in the risk of relapse with VYVGART Hytrulo compared to placebo was shown in a subgroup analysis of Chinese individuals.
Furthermore, 78% of Chinese individuals showed clinical improvement during the open-label period of the study.
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The safety and tolerability profile of VYVGART Hytrulo was also favourable among the Chinese participant group, consistent with global trial participants.
Zai Lab holds an exclusive license agreement with argenx to develop and commercialise VYVGART Hytrulo in Greater China.
Zai Lab Global Research and Development head Rafael G Amado said: “We are pleased to receive NMPA approval for VYVGART Hytrulo, marking a groundbreaking milestone for CIDP patients in China.
“This approval brings a much-needed treatment option to patients who have been suffering from CIDP for far too long. We will continue to work with argenx to explore the potential in other immunoglobulin G (IgG)-mediated autoimmune indications.”
argenx CEO Tim Van Hauwermeiren said: “VYVGART Hytrulo is a precision therapy for patients living with CIDP, many of whom have been waiting for a new treatment innovation.
“We are grateful to our partners at Zai Lab for collaborating with argenx to reach CIDP patients in China, and to the NMPA for approving VYVGART Hytrulo for CIDP.”
In May this year, China’s Centre for Drug Evaluation (CDE) accepted the sBLA with a priority review designation for VYVGART Hytrulo for CIDP.
Last month, the CDE granted breakthrough status for the therapy.
In July this year, the NMPA approved efgartigimod for treating generalised myasthenia gravis.
